1) OBJECTIVE
To define the procedure for cleaning & Storage of FBD Finger Bag
2) SCOPE
This SOP is applicable for the cleaning & Storage of FBD Finger Bag available in the Production Department of ACME LIFE SCIENCE Baddi
3) RESPONSIBILITY
Production officer as well as QA Officer
4) ACCOUNTABILITY
Production Manager
5) REFERENCES
In House
6) ANNEXURE
ANNEXURES I: FBD Bag Issuance, Usage, Cleaning & Receipt Record
7) PROCEDURE
7.1 Cleaning Procedure
7.1.1 Upon completion of the drying operation, remove the bowl from the FBD.
7.1.2 Shake the bag & ensure the complete removal of adhered material from the finger bag.
7.1.3 Bring down the finger bag and remove the finger bag. Check the bag for its integrity.
7.1.4 Collect the potable water in a cleaned container. Take a sufficient quantity of water so that the finger bag dipped completely.
- Soak the finger bag in the container containing potable water for 10 minutes.
7.1.6 Fall over/down the bag and scrub the bag using nylon scrubber till complete removal of adhered material.
7.1.7 Drain out the water in the container.
7.1.8 Refill the container with hot water (temp. should not be less than 80°C) and allow the finger bag to soak for further 10 minutes.
7.1.9 Fall over and down the bag in the container and drain out the water.
7.1.10 Ensure the complete removal of adhered material from the finger bag.
7.1.11 Dip the finger bag into the container containing freshly collected purified water.
7.1.12 Soak the finger bags for 05 minutes. Drain out the water.
7.1.13 Remove the finger bag and squeeze it to remove the excess water.
7.1.14 Assemble the finger bag with FBD ring and dry the finger bag at 60°C inlet temperature for 45 minutes.(Ensure that FBD cleanness when assembling finger bag with FBD ring. )
7.1.15 Bring down the bag and check for dryness. If required then re-dry the bag for a further 15
minutes at 60°C inlet temperature.
7.1.16 Remove the dried finger bag from FBD.
7.1.17 Put the dried finger bag in a cleaned double polybag and tie it.
7.1.18 Insert the duly filled and signed “Cleaned” label between the first and second polybag.
7.1.19 Transfer the bag to the bag storage area and stored it in the dedicated container.
7.1.20 Record the details in FBD Bag Issuance, Usage, Cleaning & Receipt Record.
FBD BAG ISSUANCE, USAGE, CLEANING & RECEIPT RECORD
FBD BAG ID NO:
| Name of Product | Batch No. | Issued on | Used on | Cleaned on | Returned on | Bag Integrity (OK/Not OK) | Checkd By |
Verified By | Remarks | |
| Before use | After use | |||||||||